Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000172000
Ethics application status
Approved
Date submitted
18/02/2010
Date registered
23/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of occlusal splints on sore ear.
Scientific title
Effects of flat occlusal splints on aural symptoms related to temporomandibular joint disorders in patients attending an otorhinolaryngology outpatient service.
Secondary ID [1] 1418 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular joint disorders causing aural symptoms 256845 0
Condition category
Condition code
Musculoskeletal 256994 256994 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Flat occlusal splints were constructed on mounted casts and made in heat-cured resin. The splints covered teeth and/or prosthesis of one of the arches. They were supposed to be worn continuoslly 24 hours per day, being removed only for meals and cleaning. The intervention extended for 90 days. After that, patients were conducted to further necessary dental treatment.
Intervention code [1] 256041 0
Treatment: Devices
Comparator / control treatment
Uncontolled.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257883 0
Improvement of ear pain measured by a Visual Analogue Scale.
Timepoint [1] 257883 0
Baseline, 07, 30, 60 and 90 days
Primary outcome [2] 257885 0
Improvement of vertigo. Vertigo was evaluated by its presence or abscense, throught interview.
Timepoint [2] 257885 0
Baseline, 07, 30, 60 and 90 days
Secondary outcome [1] 263339 0
Improvement of tinnitus. Tinnitus was evaluated by its presence or abscense, throught interview.
Timepoint [1] 263339 0
Baseline, 07, 30, 60 and 90 days

Eligibility
Key inclusion criteria
Patients attending an otorhinolaryngology outpatient service with aural symptoms, regardless of pain, temporomandibular joints sounds, and dental status.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Volunteers reporting having had accidents;
- Mental or physical debility;
- Cronic degenerative diseases;
- Present orthodontic treatment;
- Pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 2499 0
Brazil
State/province [1] 2499 0
Amazonas

Funding & Sponsors
Funding source category [1] 256544 0
Government body
Name [1] 256544 0
FAPEAM, Fundacao de Amparo a Pesquisa do Amazonas
Country [1] 256544 0
Brazil
Primary sponsor type
Individual
Name
Brigitte Nichthauser
Address
Rua 03, casa 35 – Conjunto Huascar Angelim – Aleixo
CEP: 69060-220 – Manaus - Amazonas
Country
Brazil
Secondary sponsor category [1] 255845 0
Individual
Name [1] 255845 0
Frederico Andrade e Silva
Address [1] 255845 0
Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Protese Periodontia.
Av. Limeira, 901 - Areiao
CEP: 13414-903 - Piracicaba, Sao Paulo - Caixa-Postal: 52
Country [1] 255845 0
Brazil
Other collaborator category [1] 1126 0
Individual
Name [1] 1126 0
Luiz Carlos Nadaf de Lima
Address [1] 1126 0
Av. Joao Valerio, 68 - Sao Geraldo
CEP: 69053-140 - Manaus - Amazonas
Country [1] 1126 0
Brazil
Other collaborator category [2] 1127 0
Individual
Name [2] 1127 0
Luanny Gomes Moura
Address [2] 1127 0
Rua Ramos Ferreira, 377, casa 100, Aparecida
CEP: 69010-440, Manaus, Amazonas
Country [2] 1127 0
Brazil
Other collaborator category [3] 1130 0
Individual
Name [3] 1130 0
Paulo Jose Benevides dos Santos
Address [3] 1130 0
Av. Francisco Orellana, 215 - Dom Pedro
CEP: 69040-010, Manaus, Amazonas
Country [3] 1130 0
Brazil
Other collaborator category [4] 1132 0
Individual
Name [4] 1132 0
Maria de Fatima Ribeiro Rodrigues
Address [4] 1132 0
Av. Joao Valerio, 97 - Sao Geraldo
CEP: 69053-140, Manaus, Amazonas
Country [4] 1132 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258587 0
Comite de Etica em Pesquisa da Universidade Federal do Amazonas
Ethics committee address [1] 258587 0
Rua Terezina, 4950 -Adrianopolis
CEP: 69057-070, Manaus, AM
Ethics committee country [1] 258587 0
Brazil
Date submitted for ethics approval [1] 258587 0
Approval date [1] 258587 0
16/10/2008
Ethics approval number [1] 258587 0
0187.0.115.167-08

Summary
Brief summary
The use of occlusal splints is a well known therapy for pain relief in Temporomandibular Joint Disorders, which may include otological symptoms. The aim of this study is to assess flat occlusal splints effects on patients with aural symptoms related to Temporomandibular Joint Disorders. Twenty-five Temporomandibular Joint Disorders patients that presented for treatment in an otorhinolaryngological outpatient service were selected and received flat occlusal splints constructed on mounted casts. Pain was measured with a modified visual analogue scale (VAS) on baseline and after, seven, thirty, sixty and ninety days, as well as presence of vertigo, aural fullness and tinnitus. Auditive function and radiographic appearance of temporomadibular joint was evaluated on baseline and after 90 days using the flat occlusal splints. In each follow-up session patients were evaluated regarding stability and comfort of splints.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30858 0
Address 30858 0
Country 30858 0
Phone 30858 0
Fax 30858 0
Email 30858 0
Contact person for public queries
Name 14105 0
Brigitte Nichthauser
Address 14105 0
Rua 03, casa 35 – Conjunto Huascar Angelim – Aleixo
CEP: 69060-220 – Manaus - Amazonas
Country 14105 0
Brazil
Phone 14105 0
+ 55 92 99887198
Fax 14105 0
+ 55 92 36387761
Email 14105 0
[email protected]
Contact person for scientific queries
Name 5033 0
Brigitte Nichthauser
Address 5033 0
Rua 03, casa 35 – Conjunto Huascar Angelim – Aleixo
CEP: 69060-220 – Manaus - Amazonas
Country 5033 0
Brazil
Phone 5033 0
+ 55 92 99887198
Fax 5033 0
+ 55 92 36387761
Email 5033 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.